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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01568372
Date of registration: 26/03/2012
Prospective Registration: No
Primary sponsor: St. Justine's Hospital
Public title: Efficacy of a Nurse Telephone Follow-up on Pain Intensity After Removal of Tonsils in Children
Scientific title: Efficacy of a Nurse Telephone Follow-up on Post-tonsillectomy Pain Management and Complications in Children: A Randomized Clinical Trial
Date of first enrolment: May 2010
Target sample size: 52
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01568372
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Participant).  
Phase:  N/A
Countries of recruitment
Canada
Contacts
Name:     Sylvie Le May, PhD
Address: 
Telephone:
Email:
Affiliation:  Université de Montréal
Key inclusion & exclusion criteria

Inclusion Criteria:

- ASA I or II

- Elective surgery for tonsillectomy

- Parents or children able to read, and understand French or English

- Family equipped with a phone at home

- Child discharged home after the surgery

Exclusion Criteria:

- Abused cases

- Children with a cognitive deficit

- Children suffering from chronic pain

- Child who had another surgical procedure within a month



Age minimum: 4 Years
Age maximum: 12 Years
Gender: All
Health Condition(s) or Problem(s) studied
Pain
Intervention(s)
Other: Telephone follow-up
Primary Outcome(s)
Pain intensity scores on the 3rd day after surgery [Time Frame: Pain assessed on the 3rd postoperative day]
Pain intensity scores on the 10th day after surgery [Time Frame: Pain assessed on the 10th postoperative day]
Pain intensity scores on the 5th day after surgery [Time Frame: Pain assessed on the 5th postoperative day]
Secondary Outcome(s)
postoperative complications [Time Frame: Complications assessed on the following postoperative days: First day, 3rd day, 5th day and 10th day]
Secondary ID(s)
Tonsils
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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